An ethics guideline has been launched by the PHASES Working Group to end the evidence gap for pregnant women around HIV and coinfections, according to a press release from UNC Health and UNC School of Medicine.

Pregnant women are among those most in need of safe and effective preventives and treatments for HIV and coinfections. According to the press release, they are commonly excluded from research, making them among the least likely to have robust, timely evidence to inform decisions around the use of medications.

“The resulting evidence gaps and delays are significant, and they put pregnant women and their children in harm’s way. Ethically, we must work together to give pregnant women the evidence base they deserve,” said senior author and PHASES principal investigator Anne Drapkin Lyerly, MD, in a press release.

The new report intends to change the practices in the HIV/coinfections research community so that women, providers, and policy makers can make evidence-based decisions regarding the use of medications during pregnancy.

The guidance includes 12 recommendations, such as:
  • Formalizing a global network for advocacy and resources. The global HIV/coinfections research and advocacy communities are recommended to formalize a network to develop and share a portfolio of resources to advance needed research with pregnant women. 
  • Designing for inclusion. Researchers designing trials addressing HIV/coinfections are recommended to integrate pregnant women wherever possible and optimize opportunities to gather pregnancy-specific data.
  • Ensuring equitable research on pregnant women’s own health. Agenda setters in HIV/coinfections research are recommended to commit to promoting the study of pregnant women’s own health needs as a key pillar of effort and funding. Research into fetal safety outcomes should be matched by relevant maternal outcomes assessments.
  • Enhancing post-approval safety evaluations. The HIV/coinfections research community is recommended to commit to a more regularized structure of post-approval safety evaluations to ensure both adequate pharmacovigilance and pregnant women’s timely access to important drugs.
  • Contextualizing risk findings. Those conducting HIV/coinfections research with pregnant women are recommended to anticipate possible adverse events and proactively develop communication strategies for adequately contextualizing them against baseline rates of such events.

Health, bioethics experts and advocates publish guidance for research on HIV, co-infections in pregnancy. UNC Health and UNC School of Medicine. Published July 10, 2020. Accessed July 17, 2020.